There have been many strategies to increase solubility, dissolution rates, and oral bioavailability of fenofibrate such as micronization, nanonization, solid dispersion, and emulsion so far. To our knowledge, only first three technologies have been applied in producing marketed products, and no combination of solid dispersion and pellet has been found even in laboratory-based reports. Therefore, the aim of this study was to develop novel solid dispersion-based pellets via an one-step process directly from fenofibrate powder using layering method. Developed fenofibrate pellets were in vitro characterized on size distribution, dissolution rates, sensory evaluation and stability. In addition, the transformation from crystalline fenofibrate to amorphous fenofibrate, and intermolecular interactions of fenofibrate in solid dispersion were confirmed using physico-chemical methods. The dissolution rate of pellets containing fenofibrate was significantly higher than that of the reference, Lipanthyl® 160 mg tablets at early stage, satisfying the criteria in USP 38. The pellets, then, were packed in hard capsules for bioequivalence studies in experimental beagle dogs using a validated HPLC assay. Final findings of the present study should be beneficial for further development of new fenofibrate formulations containing solid dispersion-based pellets which were bioequivalent to Lipanthyl® 160 mg tablets.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ijpharm.2019.118661 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Hollow Salt Prepared Through Spray Drying with Alginate Enhances Salinity Perception to Reduce Sodium Intake.
Foods
December 2024
SKL of Marine Food Processing & Safety Control, National Engineering Research Center of Seafood, Liaoning Key Laboratory of Food Nutrition and Health, School of Food Science and Technology, Dalian Polytechnic University, Dalian 116034, China.
Currently, high-salt diets have become one of the world's biggest dietary crisis and long-term high-salt diets are seriously detrimental to human health. In response to this situation, the present study proposed a saltiness enhancement strategy using alginate, which is a dietary fibre from brown algae and has many health benefits, such as regulating intestinal microbiota, anti-hypertension and anti-obesity. The comparison of alginates with different viscosities showed that alginate of 1000-1500 cps at a concentration of 1.
View Article and Find Full Text PDFCreation of Long-Term Physical Stability of Amorphous Solid Dispersions N-Butyl-N-methyl-1-phenylpyrrolo[1,2-a]pyrazine-3-carboxamide, Resistant to Recrystallization Caused by Exposure to Moisture.
Materials (Basel)
January 2025
Institute of Pharmacy and Biotechnology, Peoples' Friendship University of Russia n.a. P. Lumumba (RUDN), 6 Miklukho-Maklaya Str., 117198 Moscow, Russia.
Amorphous solid dispersion (ASD) technology is often used as a promising strategy to improve the solubility of active pharmaceutical ingredients (APIs). ASDs allow APIs to be dispersed at the molecular level in a polymer carrier, destroying the crystalline structure of the APIs and, thanks to the polymer, providing long-term supersaturation in solution. However, stability issues are an obstacle to the development of new medications with ASD.
View Article and Find Full Text PDFDynamic Reconstruction of the Nickel Ions' Behavior in Different Orthodontic Archwires Following Clinical Application in an Intraoral Environment.
Materials (Basel)
December 2024
G. Nadjakov Institute of Solid-State Physics, Bulgarian Academy of Sciences, 72 Tzarigradsko Chaussee, 1784 Sofia, Bulgaria.
: Orthodontic archwires undergo chemical and structural changes in the complex intraoral environment. The present work aims to investigate the safe duration for intraoral use (related to the nickel release hypothesis) of different types of nickel-containing wires. By analyzing how the nickel content (NC) varies over time, we aim to provide practical recommendations for the optimal use of said archwires.
View Article and Find Full Text PDFApplication of a New Thermal Model for the Determination of London Dispersive Properties of H-β-Zeolite/Rhodium Catalysts Using New 2D Chromatographic Models.
Materials (Basel)
December 2024
Faculty of Science and Engineering, Maastricht University, P.O. Box 616, 6200 MD Maastricht, The Netherlands.
A new methodology based on the Hamieh thermal model was applied for the determination of the surface properties of solid surfaces. The new approach consisted of the accurate quantification of the London dispersive surface energy of materials using the two-dimensional inverse gas chromatography technique at infinite dilution. This technique used the notion of the net retention volume of adsorbed molecules on the solid catalysts, allowing the determination of the free energy of adsorption.
View Article and Find Full Text PDFOptimization of Black Garlic Protein Extraction Process and Exploration of Its Properties and Functions with Enzymatic Hydrolysis Products.
Molecules
December 2024
College of Agriculture and Bioengineering, Heze University, Heze 274000, China.
This study optimized the process of extracting protein from black garlic using an alkaline dissolution and acid precipitation method through response surface methodology. The optimal extraction conditions were determined as a solid-to-liquid ratio of 1:50, an extraction time of 100 min, an extraction temperature of 30 °C, and an alkaline extraction pH of 9.0.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!